Products are increasingly being used for treatment of wounds, burns, lacerations or surgical excisions. However, to use such products, there needs to be a method of manufacturing, packaging and applying the product that maintains the integrity of the product (including membranes) during these processes. Conventional packaging for applying a biological or membrane product does not lend itself to convenient application, and had multiple failings including its inability to provide real time sizing and directionality, among others. Conventional bandages and dressings, for example, fail to adequately protect large-scale, deep, oddly shaped and other types of wounds or tissue defects. Therefore, various alternatives have been explored in the art. Among these alternatives are split- and full-thickness grafts of cadaver or porcine skin, human allografts, cultured skin equivalents and autografts. Most of these membranes, including tissue or tissue equivalent products/synthetic products contain, in at least some aspects, a morphology similar to actual human skin, which has an epithelial layer on the top and connective tissue with fibroblasts or other types of cells on the bottom facing the wound and/or damaged tissue. Such products can be considered to have directionality. Further, when such membranes are used to treat a variety of wounds (or tissue defects), the preferred orientation of the wound, tissue, graft or applied biological product is such that the connective tissue layer rests on the wound bed while the epithelial layer is away from the wound bed.
Challenges exist with conventional packaging systems for the storage, transport and the delivery or application of membranes to various human or animal structures needing treatment such as wounds or tissue defects. For example, the tensile strength of the grafts, tissues, or membranes is such that they often cannot support their own weight and tear if suspended by an edge. For this reason, these types of graft, tissue or membrane products are often mounted on a carrier paper and then packaged into a sealable container (such as a bag), which contains a substantial amount of liquid (e.g., a biomedium such as a biosolution or bioprotectant). Typically, the attachment of the graft to the carrier paper, however, is relatively weak. Thus, during manufacture, transportation to its end use site, and finally during handling prior to application to a wound (or tissue defect), the tissue or membrane may separate from the carrier paper voluntarily or inadvertently, due to shear forces of liquid moving around in the overall packaging. As a result, the tissue, graft or membrane to be applied may curl, attach to itself, attach to other aspects of the packaging, tear, or in some other fashion become unusable for final application to the human or animal. This results in significant waste, time loss, patient and/or care provider dissatisfaction and cost, and ineffective therapeutic treatment of the wound or tissue defect, among other negative attributes. In addition, if a graft or membrane product being supplied is cryopreserved, complete thawing of all ice crystals (e.g., of the biomedium or cryoprotectant contained in the container along with the tissue, graft, or membrane to be finally applied) is necessary prior to the product's final application to a human or animal. This thawing procedure can last for several minutes (e.g., up to 30 minutes or more) depending upon the volume of liquid and other material to be thawed within the packaging. This thawing wait time and additional procedure make such conventional tissue, graft or membrane products and product packaging inconvenient for health care providers who may be treating several wounds during any given period of time.
Finally, concerns also exist with current conventional application and delivery of tissue, graft or membrane-based products/systems/packages. If the membrane, tissue or graft needs to be separated from the packaging (e.g., a carrier paper or carrier bottom paper) and at the same time kept in a proper orientation (e.g., epithelial on top and connective tissue on the bottom) for delivery to the patient site such as a wound (or tissue defect), then the packaging must so indicate in a clear manner and be capable of maintaining that orientation during manufacture, transit and final application This becomes even more difficult to achieve when the size of the supplied graft, tissue or membrane is small. Once the graft, tissue or membrane folds over upon itself (or becomes disorientated in some other fashion), it is very difficult to restore the biological material to its original planar configuration, for example, and essentially impossible to make the appropriate final application to the wound.
Therefore, there is a need within the art for a new package, packaging system, composition, device, article of manufacture and method of delivery utilizing such materials that overcomes these deficiencies within the conventional art.